Needle with pre-loaded implant for snoring treatment

ABSTRACT

An apparatus for use in treating snoring of a patient suffering from snoring includes an implant of bio-compatible material sized to be embedded within the soft palate. The implant is disposed within a bore of a distal tip of a needle for penetration into the soft palate. The bore is sized to receive a rod from a proximal end of the needle with the rod opposing the implant to eject the implant from the distal tip upon relative sliding movement of said needle and said rod. The needle at the distal tip is perforated for fluid to flow through a wall of the needle into engagement with the implant. The implant is selected to altering a dynamic response of the soft palate to airflow past the soft palate.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation-in-part of U.S. patentapplication Ser. Nos. 09/513,432 and 09/513,039 filed Feb. 25, 2000,which are continuations-in-part of U.S. patent application Ser. No.09/434,653 filed on Nov. 5, 1999 which is a continuation-in-part of U.S.patent application Ser. No. 09/398,991 filed Sep. 17, 1999, now U.S.Pat. No. 6,250,307, all of which are incorporated herein by reference.

BACKGROUND

1. Field of the Invention

This invention is directed to methods and apparatuses for treatingsnoring.

2. Description of the Prior Art

Snoring has received increased scientific and academic attention. Onepublication estimates that up to 20% of the adult population snoreshabitually. Huang, et al., “Biomechanics of Snoring”, Endeavour, p.96-100, Vol. 19, No. 3 (1995). Snoring can be a serious cause of maritaldiscord. In addition, snoring can present a serious health risk to thesnorer. In 10% of habitual snorers, collapse of the airway during sleepcan lead to obstructive sleep apnea syndrome. Id.

Notwithstanding numerous efforts to address snoring, effective treatmentof snoring has been elusive. Such treatment may include mouth guards orother appliances worn by the snorer during sleep. However, patients findsuch appliances uncomfortable and frequently discontinue use (presumablyadding to marital stress).

Electrical stimulation of the soft palate has been suggested to treatsnoring and obstructive sleep apnea. See, e.g., Schwartz, et al.,“Effects of electrical stimulation to the soft palate on snoring andobstructive sleep apnea”, J. Prosthetic Dentistry, pp. 273-281 (1996).Devices to apply such stimulation are described in U.S. Pat. Nos.5,284,161 and 5,792,067. Such devices are appliances requiring patientadherence to a regimen of use as well as subjecting the patient todiscomfort during sleep. Electrical stimulation to treat sleep apnea isdiscussed in Wiltfang, et al., “First results on daytime submandibularelectrostimulation of suprahyoidal muscles to prevent night-timehypopharyngeal collapse in obstructive sleep apnea syndrome”,International Journal of Oral & Maxillofacial Surgery, pp. 21-25 (1999).

Surgical treatments have been employed. One such treatment isuvulopalatopharyngoplasty. In this procedure, so-called laser ablationis used to remove about 2 cm of the trailing edge of the soft palatethereby reducing the soft palate's ability to flutter between the tongueand the pharyngeal wall of the throat. The procedure is frequentlyeffective to abate snoring but is painful and frequently results inundesirable side effects. Namely, removal of the soft palate trailingedge comprises the soft palate's ability to seal off nasal passagesduring swallowing and speech. In an estimated 25% ofuvulopalatopharyngoplasty patients, fluid escapes from the mouth intothe nose while drinking. Huang, et al., supra at 99.Uvulopalatopharyngoplasty (UPPP) is also described in Harries, et al.,“The Surgical treatment of snoring”, Journal of Laryngology and Otology,pp. 1105-1106 (1996) which describes removal of up to 1.5 cm of the softpalate. Assessment of snoring treatment is discussed in Cole, et al.,“Snoring: A review and a Reassessment”, Journal of Otolaryngology, pp.303-306 (1995).

Huang, et al., supra, describe the soft palate and palatal snoring as anoscillating system which responds to airflow over the soft palate.Resulting flutter of the soft palate (rapidly opening and closing airpassages) is a dynamic response generating sounds associated withsnoring. Huang, et al., propose an alternative touvulopalatopharyngoplasty. The proposal includes using a surgical laserto create scar tissue on the surface of the soft palate. The scar is toreduce flexibility of the soft palate to reduce palatal flutter. Huang,et al., report initial results of complete or near-complete reduction insnoring and reduced side effects.

Surgical procedures such as uvulopalatopharyngoplasty and those proposedby Huang, et al., continue to have problems. The area of surgicaltreatment (i.e., removal of palatal tissue or scarring of palataltissue) may be more than is necessary to treat the patient's condition.Surgical lasers are expensive. The proposed procedures are painful withdrawn out and uncomfortable healing periods. The procedures havecomplications and side effects and variable efficacy (e.g., Huang, etal., report promising results in 75% of patients suggesting a fullquarter of patients are not effectively treated after painful surgery).The procedures may involve lasting discomfort. For example, scar tissueon the soft palate may present a continuing irritant to the patient.Importantly, the procedures are not reversible in the event they happento induce adverse side effects not justified by the benefits of thesurgery.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, methods andapparatuses are disclosed for treating snoring of a patient. Theinvention includes an implant of bio-compatible material sized to beembedded within the soft palate. The implant is disposed within a boreof a distal tip of a needle for penetration into the soft palate. Thebore is sized to receive a rod from a proximal end of the needle withthe rod opposing the implant to eject the implant from the distal tipupon relative sliding movement of said needle and said rod. The needleat the distal tip is perforated for fluid to flow through a wall of theneedle into engagement with the implant. The implant is selected toaltering a dynamic response of the soft palate to airflow past the softpalate.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side sectional view of a portion of a human head showing asoft palate in a relaxed state and in relation in adjacent anatomicalfeatures;

FIG. 2 is a portion of the view of FIG. 1 showing the soft palate in aflexed state;

FIG. 3 is a front view of an interior of the mouth shown in FIG. 1 andshowing an area to be ablated according to a first prior art surgicalprocedure;

FIG. 4 is the view of FIG. 3 and showing an area to be scarred accordingto a second prior art surgical procedure;

FIG. 5 is a schematic representation of a spring-mass system model ofthe soft palate;

FIG. 6 is the view of FIG. 1 with the soft palate containing an implantaccording to a first embodiment of the present invention;

FIG. 7 is the view of FIG. 3 showing the embodiment of FIG. 6;

FIG. 8 is a cross-sectional view of the implant of FIG. 6;

FIG. 9 is a first modification of the implant of FIG. 8 having a tissuein-growth layer;

FIG. 10 is a second modification of the implant of FIG. 8 having asmooth outer layer;

FIG. 11 is the view of FIG. 6 with the soft palate containing an implantaccording to a second embodiment of the present invention;

FIG. 12 is the view of FIG. 7 showing the embodiment of FIG. 11;

FIG. 13 is a perspective view of the implant of FIG. 11;

FIG. 14 is a cross-sectional view of the implant of FIG. 13;

FIG. 15 is a view of the implant of FIG. 14 with the implant pre-formedto assume the shape of a soft palate in a relaxed state;

FIG. 16 is the view of FIG. 14 with the implant constructed to havegreater flexion in a downward direction;

FIG. 17 is an exploded perspective view of first modification of theimplant of FIG. 13;

FIG. 18 is a perspective view of a modification of a housing of theembodiment of FIG. 17;

FIG. 19 is a side section view of a second modification of the implantof FIG. 13;

FIG. 20 is a cross-sectional view of an implant that is anotherembodiment of the present invention, the implant is shown in a flattenedorientation;

FIG. 21 is a cross-sectional view of the implant of FIG. 20 in anexpanded orientation;

FIG. 22 shows the implant of FIG. 20 in the flattened orientation andimplanted in the soft palate;

FIG. 23 shows the implant in FIG. 21 in the expanded orientation andimplanted in the soft palate;

FIG. 24 is a top plan view, shown partially broken away, of a stillfurther embodiment of the present invention;

FIG. 25 is a view taken along line 25—25 in FIG. 24;

FIG. 26 is a side sectional view of the implant of FIG. 24 collapsed andplaced within a delivery tool;

FIG. 27 is the view of FIG. 26 with the implant in the process of beingejected from the delivery tool;

FIG. 28 is a view taken along line 28—28 in FIG. 26;

FIG. 29 is a side sectional view of the soft palate showing a palatalmuscle in the soft palate;

FIG. 30 is the view of FIG. 29 showing the delivery tool of FIG. 26being advanced through an incision into the soft palate;

FIG. 31 is the view of FIG. 30 following delivery of the implant andremoval of the delivery tool; and

FIG. 32 is a view taken along line 32—32 in FIG. 31.

FIG. 33 is a perspective view of an implant according to a still furtherembodiment of the present invention showing only a bio-resorbable, firstcomponent;

FIG. 34 is a perspective view of the implant of FIG. 33 showing both afirst component and a second component;

FIG. 35 is a perspective of the implant of FIG. 33 showing only thesecond component following bio-resorption of the first component;

FIG. 36 is a graph showing decrease of palatal stiffening attributableto the first component and increase of palatal stiffening attributableto the first component;

FIG. 37 is a perspective view of an implant for use in the deliverysystem of FIGS. 38-39;

FIG. 38 is a side-sectional view of a delivery system for placing animplant in the soft palate;

FIG. 39 is the view of FIG. 38 following delivery of the implant fromthe delivery system;

FIG. 40 is a perspective view of a braided implant;

FIG. 41 is an end view of the implant of FIG. 40;

FIG. 42 is a side sectional view of an implant with an anchor;

FIG. 43 shows an implant in a perforated needle tip; and

FIG. 44 is a cross-sectional view of the implant and needle tip of FIG.43.

DESCRIPTION OF THE PREFERRED EMBODIMENT

For ease of understanding the present invention, the dynamics of snoringare explained with reference to FIGS. 1-4. The hard palate HP overliesthe tongue T and forms the roof of the mouth M. The hard palate HPincludes a bone support B and does not materially deform duringbreathing. The soft palate SP is soft and is made up of mucous membrane,fibrous and muscle tissue extending rearward from the hard palate HP. Aleading end LE of the soft palate SP is anchored to the trailing end ofthe hard palate HP. A trailing end TE of the soft palate SP isunattached. Since the soft palate SP is not structurally supported bybone or hard cartilage, the soft palate SP droops down from the plane ofthe hard palate HP in an arcuate geometry of repose.

The pharyngeal airway passes air from the mouth M and the nasal passagesN into the trachea TR. The portion of the pharyngeal airway definedbetween opposing surfaces of the upper surface of the soft palate SP andthe wall of the throat is the nasopharynx NP.

During normal breathing, the soft palate SP is in the relaxed stateshown in FIG. 1 with the nasopharynx NP unobstructed and with air freeto flow into the trachea TR from both the mouth M and the nostrils N.

During swallowing, the soft palate SP flexes and extends (as shown inFIG. 2) to close the nasopharynx NP thereby preventing fluid flow fromthe mouth M to the nasal passages N. Simultaneously, the epiglottis EPcloses the trachea TR so that food and drink pass only into theesophagus ES and not the trachea TR. The soft palate SP is a valve toprevent regurgitation of food into the nose N. The soft palate SP alsoregulates airflow through the nose N while talking. Since the softpalate SP performs such important functions, prior art techniques forsurgically altering the soft palate SP can compromise these functions.

The majority of snoring is caused by the soft palate SP flapping backand forth. If breathing is solely through the nose N with the mouthclosed, the trailing edge TE of the soft palate SP is sucked into thenasopharyngeal space NP obstructing the airway and subsequently fallsopening the airway in a repeating cycle. When the mouth is open, airflows over the upper and lower surfaces of the soft palate SP causingthe soft palate SP to flap up and down alternating in obstructing theoral and nasal passageways M, N. The snoring sound is generated byimpulses caused by rapid obstruction and opening of airways. Huang, etal., state the airway passage opening and closing occurs 50 times persecond during a snore. Huang, et al., utilize a spring-mass model (FIG.5) to illustrate oscillation of the soft palate in response to airflow(where the soft palate is the ball B of mass depending by a spring Sfrom a fixed anchor A).

Huang, et al., analogize the shortening of the soft palate SP inuvulopalatopharyngoplasty as effectively raising the critical air flowspeed at which soft palate flutter will occur. The shaded area SA inFIG. 3 shows the area of the trailing end TE of the soft palate SP to beremoved during this procedure. The alternative procedure proposed byHuang, et al., reduces the flexibility of the soft palate SP throughsurface scarring which is asserted as effecting the critical flow speed.The shaded area SA′ in FIG. 4 shows the area to be scarred by thisalternate procedure. In FIG. 4, dashed line L shows the demarcationbetween the soft and hard palates.

Using the spring-mass model of FIG. 5 as a convenient model of the softpalate SP, the present invention is directed to a surgical implant intothe soft palate SP to alter the elements of the model and thereby alterthe dynamic response of the soft palate SP to airflow. The implant canalter the mass of the model (the ball B of FIG. 5), the spring constantof the spring S, the dampening of the spring S or any combination ofthese elements. Unlike the prior art surgical techniques, the implantsthat will be described are easy to insert in a small incision resultingin reduced patient discomfort and are not exposed to the interior of themouth (such as the surface scarring of Huang, et al.) as a patientirritant. Also, as will be described, the degree of dynamic remodelingcan be fine tuned avoiding the need for excessive anatomicalmodification and are reversible in the event of adverse consequences.

FIGS. 6-7 illustrate a first embodiment of the present invention whereindividual units 10 of mass (in the form of implantable modular devicessuch as spheres or implants of other geometry) are imbedded in the softpalate SP in close proximity to the trailing end TE. With reference tothe model of FIG. 5, the spheres add mass to the mass-spring systemthereby altering dynamic response to airflow and adding resistance todisplacement and accelerating. The placement of the units 10 of massalso alter the location of the soft palate's center of mass furtheraltering the model and dynamic response.

The embodiment of FIGS. 6-10 is tunable to a particular patient in thatmultiple modules 10 can be implanted (as illustrated in FIG. 7). Thispermits the surgeon to progressively increase. the number of implantedmodules 10 until the altered dynamic response is such that snoringinducing oscillation is abated at normal airflow. The individual modules16 may be placed into the soft palate SP through small individualincisions closed by sutures which is much less traumatic than the grossanatomical destruction of uvulopalatopharyngoplasty or the large surfacearea scarring proposed by Huang, et al.

Preferably, such modules 10 of mass are solid modules such as spheres ofbiocompatible material which are radiopaque (or radio-marked) andcompatible with magnetic resonance imaging (MRI). Titanium is such amaterial. By way of non-limiting example, the modules 10 of mass may beabout 2-4 mm in diameter. In the case of pure, non-sintere d titanium,each such sphere 10 would add 0.15-1.22 gm of mass to the trailing endTE of the soft palate SP and contribute to re-modeling the massdistribution of the soft palate SP. An example of an alternativematerial is any biocompatible ceramic.

As shown in FIG. 9, the spheres (labeled 10′ to distinguish from theversion 10 of FIG. 8) may be sintered throughout or otherwise providedwith tissue growth inducing material 12 on their outer surface. Suchmaterial may be a sintered outer layer or a coating or covering such asa polyester fabric jacket. Such material permits and encourages tissuein-growth to secure the implant 10′ in place. Also, placement of animplant 10 or 10′ will induce a fibrotic response acting to stiffen thesoft palate SP (and further alter the dynamic response and resistance todisplacement and acceleration). A sintered or coated sphere 10′ willenhance the fibrotic response and resulting stiffening.

While tissue in-growth and enhanced fibrotic response have the benefitsdescribed above, such embodiments may make the implant 10′ moredifficult to remove in the event reversal of the procedure is desired.Therefore, as shown in FIG. 10 as an alternative, the spheres (labeled10″ to distinguish from the implants 10, 10′) may be coated with smoothcoating 14 (such as parylene or PTFE) to reduce fibrosis.

The embodiments of FIGS. 6-10 add to and relocate the mass of thespring-mass system of FIG. 5 to remodel the dynamic response. The amountof mass is selected to alter the dynamic response but not preclude thesoft palate SP being moved to close off nasal passages N duringswallowing. Through fibrotic response and incision healing, the spring Sof the model is stiffened.

In addition to modifying the mass profile of the spring-mass system, thespring component S of FIG. 5 can be modified (alone or in combinationwith mass modification) to alter dynamic response. FIGS. 11-16illustrate an implant 20 in the form of a flexible strip for placementin the soft palate. The use of the term “strip” herein is not intendedto be limited to long, narrow implants but can also include plates orother geometries implanted to alter the dynamic model of the soft palateSP. Elongated strips are presently anticipated as a preferred geometryto facilitate ease of implant.

The strip 20 has a transverse dimension less than a longitudinaldimension. By way of non-limiting example, the strip may have a lengthL_(S) of about 20-30 mm, a thickness T_(S) of about 24 mm and a widthW_(S) of 5-10 mm. As shown in FIG. 11, the strip 20 is embedded in thesoft palate SP with the longitudinal dimension L_(s) extending fromadjacent the hard palate HP toward the trailing end TE of the softpalate SP. As shown in FIG. 12, multiple strips 20 may be embedded inthe soft palate SP extending either straight rearward or angled to thesides while extending rearward. The strips 20 may be formed straight(FIG. 14) or pre-shaped (FIG. 15) to have a rest shape approximate tothe side-cross section shape of the soft palate in a relaxed state.

The strips 20 may be any flexible, biocompatible material and arepreferably radiopaque or radio-marked as well as MRI compatible. Thestrips 20 need not be elastic and having a material spring constantbiasing them to their original shape. Such strips 20 could simply beflexible, plastically deformable strips which are stiffer than the softpalate SP to reinforce the soft palate SP and assist the soft palate SPin resisting deflection due to airflow. Such stiffening of the softpalate SP stiffens and dampens the spring S in the spring-mass system ofFIG. 5 and alters the dynamic response of the soft palate SP. The strip20 may be a spring having a spring constant to further resist deflectionof the soft palate SP as well as urging the soft palate SP to therelaxed state of FIG. 5. The stiffness of the strip 20, a springconstant of the strip 20, and the number of strips 20, are selected toavoid preclusion of closure of the soft palate SP during swallowing.Examples of suitable materials include titanium and nitinol (awell-known nickel-titanium alloy). As with the examples of FIGS. 9 and10, the strips 20 may be provided with tissue in-growth surfaces or maybe coated as desired. Also, the strips may be structurally modified tocontrol their flexibility. In FIG. 16, the bottom 22 of the strip 20(facing the tongue after placement) is provided with transverse notches24 to enhance downward flexion of the strip 20 relative to upwardflexion of the strip 20 following placement.

FIG. 17 provides an alternative to the strips 20 of FIG. 13. In FIG. 17,the strip 20′ includes a housing 26 having an interior space 28 with anaccess opening 25. The interior space 28 extends in the longitudinaldimension of the housing 26. The strip 20′ further includes alongitudinal insert 32 sized to be passed through the access opening 25and into the space 28. By way of non-limiting example, the housing 26could be silicone rubber (with radio-markers, not shown, to indicateplacement) and the inserts 32 could be titanium rods or other flexiblemember. With the embodiment of FIG. 17, the housing 26 (without aninsert) may be embedded in the soft palate SP. The housing 26 actsindependently as a stiffening strip to add stiffness to the soft palateSP to alter the soft palate's dynamic response. In the event furtherstiffening or a spring action is desired, the implant 20′ can beselectively tuned to the patient's unique dynamic model by placing theinsert 32 into the space 28 at the time of initial surgery or during asubsequent procedure. The embodiment of FIG. 17, permits selection of aninsert 32 from a wide variety of materials and construction so that aninsert 32 of desired characteristics (e.g., stiffness and spring action)can be selected to be inserted in the space 28 and alter the dynamicresponse as desired. The embodiment of FIG. 17 also, permits laterremoval of the insert 32 and replacement with a different insert 32 ofdifferent properties for post-surgery modification of the soft palate'sdynamic response.

The embodiment of FIG. 18 is similar to that of FIG. 17. The housing 26′is provided with multiple, parallel-aligned interior spaces 28′ andaccess openings 25′. In addition to the function and benefits of theembodiment of FIG. 17, the number of inserts 32 may be varied to alterand adjust the dynamic response of the soft palate SP.

FIG. 19 illustrates a still further embodiment of the strip implant. InFIG. 19, the strip 20′″ is a bladder having a housing 26″ in the form ofa completely sealed envelope of flexible synthetic material defining aninterior space 28″. The envelope 26″ is preferably self-sealingfollowing needle injection. Fluid is injected into the housing 26″(e.g., through hypodermic needle 40 injection) to stiffen the strip20′″. Addition of fluid further stiffens the strip 20′″ and furtheralters the dynamic response of the soft palate SP. Removal of fluidincreases the flexibility. Unlike the embodiments of FIG. 17 (whereinserts 32 are most effectively replaced post-operatively throughincision to alter flexibility), the embodiment of FIG. 19 permitsselectively varying flexibility of the soft palate SP through needleinjection. An alternative to FIG. 19 is to fill the space 28″ with aso-called phase change polymer and inject a stiffening agent into thespace 28″ to alter the flexibility of the polymer.

FIGS. 20-23 illustrate a still further embodiment of the presentinvention. In the foregoing embodiments, the spring-mass system of FIG.5 is altered by altering the mass of the soft palate SP or the springcharacteristics of the soft palate SP. The dynamic response can also bealtered by altering the force acting on the spring-mass system. Namely,the force acting on the soft palate SP is generated by airflow over thesurface of the soft palate. The soft palate acts as an airfoil whichgenerates lift in response to such airflow. By modifying thelongitudinal (i.e., anterior to posterior) cross-sectional geometry ofthe soft palate SP, the aerodynamic response and, accordingly, thedynamic response are altered.

In the embodiments of FIGS. 20-23, the implant 30 is inserted into thesoft palate SP through an incision. The implant 30 has an oval shape tocause deformation of the geometry of the soft palate SP. Prior toimplantation, the implant 30 is preferably formed as a flat oval (FIGS.20 and 22) for ease of insertion. After implantation, the implant 30expands to an enlarged oval (FIGS. 21 and 23). While such expansioncould be accomplished mechanically (i.e., through balloon expansion),the implant 30 is preferably formed as a,shape-memory alloy (such asnitinol) which expands to the enlarged shape in response to the warmthof the body. In addition to changing the aerodynamics of the soft palateSP, the implant 30 can be constructed with a mass and stiffness asdesired to alter the spring and mass components of the spring-masssystem of FIG. 5.

FIGS. 24-32 illustrate an expandable implant 50 and a delivery tool 60for placing the implant 50 in the soft palate SP through a smallincision. In FIGS. 24 and 25, the implant 50 is best illustrated as aflexible rim 52 with a fibrosis-inducing agent in the form of a flexiblematerial, for example polyester fabric 54, retained on the rim 52. Therim 52 may be titanium or other material and resiliently biased to arest geometry shown as an oval in FIG. 24 having a fully expanded widthW and a length L. An oval is illustrated as a preferred geometry butother geometries may suffice. The geometries may include geometriesselected to alter the shape of the soft palate SP. The polyester fabric54 (such as Dacron® or the like) contains interstitial spaces forfibrosis and tissue integration to impart a stiffening to the softpalate SP.

The soft palate SP is schematically shown in FIGS. 29-32 with a palatalmuscle PM extending distally from the bone B of the hard palate andsurrounded by the soft tissue ST of the soft palate SP. The implant 50is placed by compressing the implant 50 against the bias of the rim 52into a compact cylindrical shape of length L and placing the compressedimplant 50 in a distal end of a cylindrical delivery tool 60. The distaltip 62 of tool 60 is a blunt beveled end to follow an incision and toseparate tissue as the tip 62 is advanced. A rod 64 is positionedproximal to the implant 50. The distal tip 62 comprises a severable flap68 such that pushing rod 64 urges the implant 50 out of the distal tip62. When removed from the delivery tool 60, the implant 50 springs backto an oval geometry.

The implant 50 is placed by forming a small incision 70 in the softpalate. In FIG. 29, the incision is made on the lower surface of thesoft palate. The procedure could also be performed through the uppersurface of the soft palate. The incision is sized to pass the distal tip62 of tool 60 which is substantially smaller than the full width W ofthe expanded implant 50.

Any suitable blunt dissecting tool may be inserted into incision 70 toseparate the soft tissue ST from the palatal muscle PM by an amountsufficient to receive the expanded implant 50. The distal tip 62 isplaced through the incision 70 and advanced through the soft palate SPwith the distal tip 62 separating the soft tissue ST and the palatalmuscle PM (FIG. 30). The tool 60 can be advanced by the physiciantactilely noting position of the tool 60 or through any visualizationtechnique (e.g., an endoscope on the distal tip 62). When the distal tip62 is fully advanced, the outer tube 66 of tool 60 is retracted whileholding rod 64 in place causing the implant 50 to be expelled throughthe distal tip 62. After full expulsion of the implant 50, tool 60 isremoved through incision 70. The released implant 50 then expands intothe oval shape and residing between the palatal muscle PM and the softtissue ST (FIGS. 31 and 32).

In place, the fabric 54 of implant 50, encourages fibrosis andstiffening of the soft palate SP. By inserting a collapsed implant 50through a small incision 70, a large surface area of fibrosis (andgreater stiffening) can be achieved with a minimized incision 70(resulting in reduced patient discomfort). Also, while the implant 50 isillustrated as being resiliently expandable, the implant 50 could expandor swell in response to other factors such as shape memory alloys (e.g.,nitinol), smart polymers and balloon expandable and plasticallydeformable metals.

As an alternative to the foregoing, a catheter (not shown) can be passedthrough incision 70 and passed through the soft palate SP. The deliverytool 60 can be passed through the catheter. If desired, a coring tool(not shown) can be passed through the catheter to remove tissue from thesoft palate SP prior to placing the implant 50 (or any implant of theprevious embodiments). Also, for small implants, an implant can beplaced through any short tube inserted into the soft palate through aneedle poke and need not include a pre-incision.

With reference to FIGS. 33-36, a still further embodiment of theinvention is described. In FIGS. 33-36, an implant 80 is shown having acylindrical shape. The shape is illustrative only. The implant 80 may bedeployed through a delivery tool 60 as previously described.

The implant 80 includes two stiffening components. A first component 82is a base of a bio-resorbable material such as bio-resorbable sutureformed into a woven cylindrical shape. Such material has a stiffnessgreater than soft tissue and is absorbed into the body over time. Anexample of such material is synthetic absorbable suture such aspolydioxanone suture sold by Ethicon, Inc. under the trademark PDS II.Alternative materials could include absorbable bio-adhesives. A firstcomponent as described provides immediate post-operative stiffening toreduce or eliminate snoring immediately following placement of theimplant 80 in the soft palate.

The second component 84 is any fibrosis inducing material combined withthe first component 82. By way of non-limiting example, the secondcomponent may be filaments of polyester or polyester fabric (such asDacron®) intertwined in the interstitial spaces of the first component82. The presence of the second component 84 in the soft tissue of thesoft palate SP induces fibrosis which stiffens the soft palate to reduceor eliminate snoring. The stiffening increases with time followingimplantation until the fibrotic response is steady state. The polyestersecond component 84 is permanent and does not bio-resorb. Therefore, thefibrosis effect (and, hence, the snoring reducing stiffening) remainspermanently following implantation and following complete absorption ofthe first component 82.

The first component 82 and the second component 84 cooperate for theimplant 80 to provide effective stiffening immediately post-operativelyand chronically thereafter. The first component has a stiff materialwhich stiffens the soft palate SP upon placement. However, over time,the first component is absorbed and the stiffening influence reduces andis eliminated. The second component 84 is formed of very floppy materialwhich does not materially stiffen the soft palate immediately uponimplantation of implant 80. However, with time, fibrosis induced by thematerial of the second component 84 stiffens the soft palate. Thisphenomena is illustrated in the graph of FIG. 36 in which the horizontalaxis represents time and the vertical axis represents stiffeningprovided by the implant 80. Line A is stiffening attributable to thefirst component 82 (which decays to zero as the first component isabsorbed). Line B represents stiffening attributable to the secondcomponent (which is at near zero at implantation and increases to amaximum representing a steady-state level of fibrosis). Line Crepresents stiffening of the soft palate SP which is a sum of thestiffening of lines A and B.

Therefore, with the embodiment of implant 80, immediate post-operativestiffening (and snoring abatement) is achieved. Chronic stiffening isprovided by fibrotic response which is permanent. Total stiffening iscontrolled since the first component 82 is being absorbed as thefibrosis at the second component 84 increases.

FIGS. 37-39 show an alternative delivery system 100 for placing animplant in the soft palate SP. FIGS. 37-39 illustrate use of the noveldelivery system 100 with a cylindrical implant 102 (such as implant 80of FIG. 34). However, the method and apparatus described with referenceto FIGS. 37-39 could also be used with other geometries (e.g., thespherical implants of FIG. 7 or rectangular cross-section implants ofFIG. 13) as well as an expandable implant as such implant 50 of FIG. 24.

A needle 66′ is provided having a ground beveled distal tip 61′ forpiercing tissue of the soft palate. The needle 66′ is hollow and carriesthe implant 102 in sliding close tolerance. A rod 64′ is slidablypositioned in the needle 66′ proximal to the implant 102. As describedabove with reference to FIGS. 26-32, the implant 102 is carried by theneedle 66′ to a desired implant site within the soft palate. At thedesired site, the implant 102 is deployed by retracting the needle 66′while holding the rod 64′ in place. Relative movement between the rod64′ and needle 66′ causes the rod 64′ to dispel the implant 102 from theneedle 66′ without need for moving the implant 102 relative to the softpalate.

While advancing the needle 66′ through the soft palate, tissue and bodyfluids may be inclined to enter the needle 66′ and later interfere withdischarge of the implant 102 from the needle 66′. The embodiment ofFIGS. 26-27 avoids such introduction of tissue and fluids into needle 60by use of a flap 68 on the distal tip 62 of the needle 66. Theembodiment of FIGS. 38-39 provides an alternative technique to preventadmission of tissue into the needle 66.

In FIGS. 38-39, the needle 66′ is provided with a plug 104 at the distaltip 61′. Preferably, the plug 104 is a bio-resorbable material (such asthe material of the first component 82 of the implant 80 of FIG. 34.).After placing the plug 104 in the needle 66′ at the distal tip 61′, thedistal tip 61′ may be ground to a final bevel resulting in the plug 104assuming the shape of the distal tip of 61′ as shown in FIGS. 38-39.

During discharge, the rod 64′ (due to retraction of the needle 66′)urges both the plug 104 and implant 102 out of the needle 66′. Since theplug 104 is bio-resorbable, it resorbs into the patient's body overtime. The implant 102 provides the therapeutic effect described abovewith reference to altering the dynamic response of the soft palate.

To avoid the plug 104 being urged proximally into the needle 66′, theneedle 66′ includes a first bore 66 a′ having a diameter approximate tothat of the rod 64′ and implant 102 and a second bore 66 b′ at thedistal tip 61′. The second bore 66 b′ is coaxial with the first bore 66a′ and is larger than the first bore 66 a′ so that an annular retainingedge 65′ is defined within the needle 66′. The plug 104 abuts theretaining edge 65′ and is restricted from being urged into the needle66′ as the needle 66′ is advanced through the tissue of the soft palate.

The needle 66′ may be porous at the distal tip 61′ so the needle with aloaded implant 102 may be soaked for sterilization. FIGS. 43-44illustrate an implant in a perforated needle tip having through-holes69′ for perforations. No plug (such as plug 104) is shown in FIGS. 43-44to illustrate the needle 66′ can be used with or without a plug (inwhich case the needle 66′ has a constant diameter bore 67′). With theperforated needle, the implant 102 can be pre-loaded into the distal tipof the needle at time of assembly. This frees a physician from thecumbersome task of loading the implant into a needle. At or shortlybefore the implantation in the palate, the physician may soak the needledistal tip in a solution of antibiotic (such as well known antibioticsGentamycin or Betadine). The fluid antibiotic flows through perforations69′ in the needle and soaks the implant 102. As a result, a combinedneedle and implant can be fabricated economically with the combinationreadily treatable with antibiotic and with the needle disposablefollowing placement of the implant. During loading, the implant may besized larger than the needle bore 67′. Therefore, the implant expandsfollowing discharge

FIGS. 40-41 illustrate an implant 102′ formed of twisted or braidedfibers 103 a, 103 b. While a single type fiber could be used, theembodiment is preferably formed of two different fibers 103 a, 103 bbraided or twisted together. One fiber 103 a may be provided forencouraging fibrotic response. Such a fiber 103 a may be polyester orsilk suture material (in which individual fibers 103 a may be formed ofbraided or twisted elements). The other fiber 103 b may be abio-resorbable fiber as in FIG. 33 (e.g., bio-resorbable suture materialwhich may include natural materials such as collagen or syntheticmaterials such as the PDS suture material previously described).Alternatively, the second fiber 103 b may be a non-resorbable materialsuch as polypropylene suture material to provide added stiffness to theimplant. The fibers 103 a, 103 b may be bonded together along the axiallength of the implant 102′ to provide added stiffness.

Referring to FIG. 42 and using implant 102 of FIG. 37 as an example, adistal end 102 a of the implant 102 (i.e., the first end of the implant102 to be discharged from needle 66′) may be scored or otherwiseprovided with an anchor 103 to flair outwardly following discharge fromthe needle 66′. Such flaring aids to anchor the implant 102 in placewhile tissue in-growth matures. Such flaring can also be provided byradially extending fibers on the, implant 102 which are folded down inthe needle and which would radially project in the event the implantwere to follow the needle 66′ during needle retraction.

A braiding operation as described with reference to FIGS. 40-41 providesenhanced design flexibility. Such braiding can incorporate manydifferent types of fibers for various functions. For example,radio-opaque fibers may be provided in the braid to permit visualizationof the implant under fluoroscopy. The structure (and flexibility) of thebraided implant can be varied by adding a core material to the braid orvarying tightness of the braid. FIGS. 40 and 41 show a core or centralfiber 105. The central fiber 105 may be the same material as either offibers 103 a, 103 b or may be a different material to add stiffness orother mechanical property. For example, the fibers 103 a, 103 b may benon-bio-resorbable while core 105 is resorbable. Core 105 may be metalto add stiffness or be radio-opaque. Core 105 may be a coil orspring-shape core. In the construction of the braided implant 102′, allfibers 103 a, 103 b and core 105 are preferably co-terminus with theimplant 102′. In other words, the ends of the fibers 103 a, 103 b andcore 105 are positioned at the axial ends of the implant 102′. The endsmay be heat treated or otherwise adhered to prevent unraveling of thebraided implant 102′.

The foregoing describes numerous embodiments of an invention for animplant for the soft palate to alter a dynamic response of the softpalate. The invention is much less traumatic than prior surgicaltreatments. Further, the invention permits use of reversible proceduresas well as procedures which can be selectively tuned both during surgeryand post-operatively. Having described the invention, alternatives andembodiments may occur to one of skill in the art. For example, thestrips of FIG. 13 may be encased coiled springs which may be tightenedto further stiffen the strips. Such strips may also be hinged segments.Also, the present invention can cover any fibrosis inducing agent (e.g.,polyester fabric, with or without heat application or chemicalapplication—such as ethyl alcohol, or such application in a manner tocreate a permanent scar with the soft palate) placed into the softpalate to stiffen the soft palate. For example, such chemical may beintroduced through incision 70 or a heat source may be inserted throughincision 70. The present invention need not be repeated to continueefficacy since the stiffening is permanent. It is intended that suchmodifications and equivalents shall be included within the scope of thefollowing claims.

What is claimed is:
 1. A kit for use in treating snoring of a patient suffering from snoring attributable, at in least in part, to a snoring sound generated by oscillation of a soft palate of said patient in response to airflow past said soft palate and where said soft palate has a characteristic dynamic response to said airflow prior to treatment, said kit comprising the following in combination: an implant of bio-compatible material sized to be embedded within said soft palate; a needle having a distal tip for penetrating into the soft palate, said needle having an axially extending bore; said implant disposed within said bore at said distal tip; said bore sized to receive a rod from a proximal end of said needle with said rod opposing said implant to eject said implant from said distal tip upon relative sliding movement of said needle and said rod; and said needle at said distal tip being perforated through a wall thickness of said needle in a region of said needle in fluid flow communication with said implant for fluid to flow through a wall of said needle into engagement with said implant.
 2. A kit according to claim 1 wherein said implant is provided with a stiffness to alter a dynamic response of said palate following placement of said implant in said soft palate.
 3. A kit for use in treating snoring of a patient suffering from snoring attributable, at in least in part, to a snoring sound generated by oscillation of a soft palate of said patient in response to airflow past said soft palate and where said soft palate has a characteristic dynamic response to said airflow prior to treatment, said kit comprising the following in combination: an implant of bio-compatible material sized to be embedded within said soft palate; a needle having a distal tip for penetrating into the soft palate, said needle having an axially extending bore; said implant disposed within said bore at said distal tip; said bore sized to receive a rod from a proximal end of said needle with said rod opposing said implant to eject said implant from said distal tip upon relative sliding movement of said needle and said rod; said needle at said distal tip being perforated for fluid to flow through a wall of said needle into engagement with said implant; and wherein said implant includes a material for promoting tissue in-growth into said implant following placement of said implant into said soft palate.
 4. A kit according to claim 1 wherein said implant is sized slightly greater than said bore for said implant to expand upon ejection from said bore.
 5. A kit for use in treating snoring of a patient suffering from snoring attributable, at in least in part, to a snoring sound generated by oscillation of a soft palate of said patient in response to airflow past said soft palate and where said soft palate has a characteristic dynamic response to said airflow prior to treatment, said kit comprising the following in combination: an implant of bio-compatible material sized to be embedded within said soft palate; a needle having a distal tip for penetrating into the soft palate, said needle having an axially extending bore; said implant disposed within said bore at said distal tip; said bore sized to receive a rod from a proximal end of said needle with said rod opposing said implant to eject said implant from said distal tip upon relative sliding movement of said needle and said rod; said needle at said distal tip being perforated for fluid to flow through a wall of said needle into engagement with said implant; wherein said implant is provided with a stiffness to alter a dynamic response of said palate following placement of said implant in said soft palate; and wherein said implant is formed of multiple fibers including fibers of said material for promoting tissue in-growth.
 6. A kit for use in treating snoring of a patient suffering from snoring attributable, at in least in part, to a snoring sound generated by oscillation of a soft palate of said patient in response to airflow past said soft palate and where said soft palate has a characteristic dynamic response to said airflow prior to treatment, said kit comprising the following in combination: an implant of bio-compatible material sized to be embedded within said soft palate; a needle having a distal tip for penetrating into the soft palate, said needle having an axially extending bore; said implant disposed within said bore at said distal tip; said bore sized to receive a rod from a proximal end of said needle with said rod opposing said implant to eject said implant from said distal tip upon relative sliding movement of said needle and said rod; said needle at said distal tip being perforated for fluid to flow through a wall of said needle into engagement with said implant; wherein said implant is sized slightly greater than said bore for said implant to expand upon ejection from said bore; and wherein the multiple fibers are twisted together along a length of the implant with the fibers having terminal ends at opposite ends of the implant.
 7. A kit according to claim 5, wherein the multiple fibers are braided together. 